Magseed Magnetic Marker Localization

• Sponsor: Endomagnetics Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03020888
• Collaborator: M.D. Anderson Cancer Center (Other)
• Enrollment: 120
• Location: 1
• Arm: 1
• Actual Duration (Months): 17.9
• Patients Per Site Per Month: 6.7

Study Details

Study Description

Brief Summary

The purpose of this post-marketing study is to provide prospective evidence that the Magseed and Sentimag® is effective for lesion localization in patients undergoing surgical excision of a breast lesion and to summarize measures of product safety and performance.

Condition or Disease	Intervention/Treatment	Phase
Disorders of Breast; Breast Lesions	Device: Magseed and Sentimag	N/A

Detailed Description

This is a post-market, prospective, open label, single arm study of Magseed and Sentimag in patients undergoing surgical excision of a breast lesion.

Subjects will have the Magseed marker deployed under imaging guidance up to thirty days prior to surgery.

The Magseed marker will be localized using the Sentimag system during surgery and removed with the lesion.

After the lumpectomy procedure, subjects will be evaluated for safety and patient reported outcomes.

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Open Label, Post Marketing Study of Magseed and Sentimag in Patients Undergoing Surgical Excision of a Breast Lesion That Requires Preoperative Radiographic Localization
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Feb 1, 2018
• Actual Study Completion Date: Jul 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Magseed and Sentimag Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery. Marker located during surgery using the Sentimag system, and removed with the lesion.	Device: Magseed and Sentimag; Magseed marker and Sentimag probe for lesion localization

Outcome Measures

Primary Outcome Measures

1. Percent of Participants With Retrieval of Index Lesion and Magseed [Time of surgery on average 16 minutes]

   Percent retrieval rate of the index lesion and Magseed in the initial excised specimen. This is defined as the number of subjects in whom the index lesion and Magseed are retrieved in the initial excised specimen divided by the total number of subjects undergoing surgery.

Secondary Outcome Measures

1. Number of Device Related Adverse Events [8 weeks]

   Rates of device-related adverse events and device-related serious adverse events

2. Percent of Participants With Radiological Ease of Placement Rated as Very Easy, or Fairly Easy [At the time of marker deployment on average 8.39 minutes]

   Radiologist were asked to rate ease of marker placement graded from Very easy, Fairly Easy & Difficult after each marker placement.

3. Percentage of Markers With Radiological Placement Accuracy Measured as <5mm to Lesion [At time of marker deployment on average 8.39 minutes]

   Success rate of Magseed placement relative to the lesion (placement accuracy) measured as <5mm to lesion; 5-10mm to lesion; >10 mm to the target

4. Percentage of Participants With Re-excision [During surgery on average 16 minutes]

   Overall re-excision rate and re-excision rate necessary to remove the Magseed or targeted lesion

5. Percent of Participants With Surgical Ease of Localization - Rated Fairly or Very Easy [At time of surgery on average 16 minutes]

   Surgeon rated ease of localization during surgery assessed for each procedure as either very easy, fairly easy, fairly difficult, difficult, unable to localise

6. Surgical Localization - Duration of Localization [At time of surgery on average 16 minutes]

   Duration of the lumpectomy procedure, time taken to remove the lesion

7. Percentage of Participants With Marker Retrieval Rated as Fairly or Very Easy [On the day of surgery]

   Pathologist rated ease of marker identification and retrieval as: 1) Unable to retrieve 2) Difficult 3) Fairly difficult 4)fairly easy 5) very easy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects with a breast lesion requiring image-guided localization prior to excision.

• Subjects aged 18 years or more at the time of consent.

Exclusion Criteria:

• The subject is pregnant or lactating.

• Subject has pacemaker or other implantable device in the chest wall.

• Subject has current active infection at the implantation site in the breast (per investigatordiscretion)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030-4008

Sponsors and Collaborators

• Endomagnetics Inc
• M.D. Anderson Cancer Center

Investigators

• Principal Investigator: Kelly Hunt, MD, MD Anderson

Study Documents (Full-Text)

• Study Protocol - Dec 30, 2016
• Statistical Analysis Plan - Jun 24, 2018

More Information

Publications

None provided.

• Responsible Party: Endomagnetics Inc
• ClinicalTrials.gov Identifier: NCT03020888
• Other Study ID Numbers: US-002; NCT03019445
• First Posted: Jan 13, 2017
• Last Update Posted: Feb 4, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Breast Diseases

Study Results

Participant Flow

Arm/Group Title	Magseed and Sentimag
Arm/Group Description	Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery. Marker located during surgery using the Sentimag system, and removed with the lesion. Magseed and Sentimag: Magseed marker and Sentimag probe for lesion localization
Period Title: Overall Study
STARTED	120
COMPLETED	107
NOT COMPLETED	13

Baseline Characteristics

Arm/Group Title	Magseed and Sentimag
Arm/Group Description	Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery. Marker located during surgery using the Sentimag system, and removed with the lesion. Magseed and Sentimag: Magseed marker and Sentimag probe for lesion localization
Overall Participants	107
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	60.73 (11.58)
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	60.73 (11.58)
Sex: Female, Male (Count of Participants)
Female	107 100%
Male	0 0%
Race and Ethnicity Not Collected (Count of Participants)
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	28.83 (5.91)

Outcome Measures

1. Primary Outcome

Title	Percent of Participants With Retrieval of Index Lesion and Magseed
Description	Percent retrieval rate of the index lesion and Magseed in the initial excised specimen. This is defined as the number of subjects in whom the index lesion and Magseed are retrieved in the initial excised specimen divided by the total number of subjects undergoing surgery.
Time Frame	Time of surgery on average 16 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Magseed and Sentimag
Arm/Group Description	Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery. Marker located during surgery using the Sentimag system, and removed with the lesion. Magseed and Sentimag: Magseed marker and Sentimag probe for lesion localization
Measure Participants	107
Number [percentage of participants]	100 93.5%

2. Secondary Outcome

Title	Number of Device Related Adverse Events
Description	Rates of device-related adverse events and device-related serious adverse events
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Magseed and Sentimag
Arm/Group Description	Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery. Marker located during surgery using the Sentimag system, and removed with the lesion. Magseed and Sentimag: Magseed marker and Sentimag probe for lesion localization
Measure Participants	107
Number [Number of device related adverse events]	0

3. Secondary Outcome

Title	Percent of Participants With Radiological Ease of Placement Rated as Very Easy, or Fairly Easy
Description	Radiologist were asked to rate ease of marker placement graded from Very easy, Fairly Easy & Difficult after each marker placement.
Time Frame	At the time of marker deployment on average 8.39 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Magseed and Sentimag
Arm/Group Description	Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery. Marker located during surgery using the Sentimag system, and removed with the lesion. Magseed and Sentimag: Magseed marker and Sentimag probe for lesion localization
Measure Participants	107
Number [% Participants]	98 91.6%

4. Secondary Outcome

Title	Percentage of Markers With Radiological Placement Accuracy Measured as <5mm to Lesion
Description	Success rate of Magseed placement relative to the lesion (placement accuracy) measured as <5mm to lesion; 5-10mm to lesion; >10 mm to the target
Time Frame	At time of marker deployment on average 8.39 minutes

Outcome Measure Data

Analysis Population Description

107 participants had 124 markers placed

Arm/Group Title	Magseed and Sentimag
Arm/Group Description	Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery. Marker located during surgery using the Sentimag system, and removed with the lesion. Magseed and Sentimag: Magseed marker and Sentimag probe for lesion localization
Measure Participants	107
Measure Markers	124
Number [percentage of markers]	95.16

5. Secondary Outcome

Title	Percentage of Participants With Re-excision
Description	Overall re-excision rate and re-excision rate necessary to remove the Magseed or targeted lesion
Time Frame	During surgery on average 16 minutes

Outcome Measure Data

Analysis Population Description

malignant breast lesions

Arm/Group Title	Magseed and Sentimag
Arm/Group Description	Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery. Marker located during surgery using the Sentimag system, and removed with the lesion. Magseed and Sentimag: Magseed marker and Sentimag probe for lesion localization
Measure Participants	98
Number [percentage of participants]	9 8.4%

6. Secondary Outcome

Title	Percent of Participants With Surgical Ease of Localization - Rated Fairly or Very Easy
Description	Surgeon rated ease of localization during surgery assessed for each procedure as either very easy, fairly easy, fairly difficult, difficult, unable to localise
Time Frame	At time of surgery on average 16 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Magseed and Sentimag
Arm/Group Description	Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery. Marker located during surgery using the Sentimag system, and removed with the lesion. Magseed and Sentimag: Magseed marker and Sentimag probe for lesion localization
Measure Participants	107
Number [percentage of participants]	86.9 81.2%

7. Secondary Outcome

Title	Surgical Localization - Duration of Localization
Description	Duration of the lumpectomy procedure, time taken to remove the lesion
Time Frame	At time of surgery on average 16 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Magseed and Sentimag
Arm/Group Description	Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery. Marker located during surgery using the Sentimag system, and removed with the lesion. Magseed and Sentimag: Magseed marker and Sentimag probe for lesion localization
Measure Participants	107
Mean (Full Range) [minutes]	5

8. Secondary Outcome

Title	Percentage of Participants With Marker Retrieval Rated as Fairly or Very Easy
Description	Pathologist rated ease of marker identification and retrieval as: 1) Unable to retrieve 2) Difficult 3) Fairly difficult 4)fairly easy 5) very easy
Time Frame	On the day of surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Magseed and Sentimag
Arm/Group Description	Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery. Marker located during surgery using the Sentimag system, and removed with the lesion. Magseed and Sentimag: Magseed marker and Sentimag probe for lesion localization
Measure Participants	107
Number [percentage of participants]	96 89.7%

Adverse Events

Time Frame	Adverse vents data was captured from the time the Magseed was implanted to 8 weeks after it was surgically removed during the index procedure
Arm/Group Title	Magseed and Sentimag
Arm/Group Description	Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery. Marker located during surgery using the Sentimag system, and removed with the lesion. Magseed and Sentimag: Magseed marker and Sentimag probe for lesion localization
All Cause Mortality
	Magseed and Sentimag
	Affected / at Risk (%)	# Events
Total	0/107 (0%)
Serious Adverse Events
	Magseed and Sentimag
	Affected / at Risk (%)	# Events
Total	0/107 (0%)
Other (Not Including Serious) Adverse Events
	Magseed and Sentimag
	Affected / at Risk (%)	# Events
Total	0/107 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.